CURATODERM OINTMENT 4--G/G

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tacalcitol

3131311

Curatoderm® 4 micrograms/g Ointment
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Curatoderm Ointment is and what it is used for
2. Before you use Curatoderm Ointment
3. How to use Curatoderm Ointment
4. Possible side effects
5. How to store Curatoderm Ointment
6. Further information

1. WHAT CURATODERM OINTMENT IS AND WHAT IT IS USED FOR

Curatoderm Ointment contains tacalcitol which is a drug that belongs to a group of medicines
called antipsoriatics and is a vitamin D derivative.
Curatoderm Ointment is used to treat a condition known as psoriasis vulgaris. Psoriasis is a skin
disorder in which itchy, red, flaky patches appear on the skin or scalp. Within affected areas of
skin, new cells are being produced faster than normal, but old dead cells are only being shed at
the normal rate. As live skin cells accumulate, the skin becomes thickened and inflamed.
Curatoderm Ointment works by slowing down cell production and bringing it back to normal and
helps reduce inflammation.

2. BEFORE YOU USE CURATODERM OINTMENT

3131311

Do not use Curatoderm Ointment
• if you are allergic (hypersensitive) to Tacalcitol or any of the other ingredients listed in sec tion 6.
• if you have ever had problems with too much calcium in your blood
• (hypercalcaemia or other disorders of calcium metabolism).
If this applies to you, do not use this medicine and speak to your doctor.
Take special care with Curatoderm Ointment
When applying Curatoderm Ointment to the face: Do not allow the Ointment to come in contact
with the eyes. If it does, rinse thoroughly with water.
Please tell your doctor if
• you have or have had problems with your kidneys,
• you have a particular type of psoriasis called generalized pustular psoriasis or erythrodermic
exfoliative psoriasis,
• you are taking high doses of vitamin D (more than 500IU)
Your doctor may want to check the level of calcium in your blood if you have any of these conditions.
Using other medicines or therapies
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Especially:
• Multivitamin products or vitamin D
If you are receiving ultraviolet (UV) therapy, this should be given in the morning and Curatoderm
Ointment used at bedtime.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The potential risk to the baby if Curatoderm Ointment is used during pregnancy is unknown.
Therefore if you are pregnant or likely to become pregnant whilst using Curatoderm Ointment
make sure your doctor knows.
It is not known if Curatoderm Ointment passes into breast milk. Only a small amount of tacal­citol
is absorbed into the body after skin treatment. It is probably not necessary to stop breast-feeding­
during treatment.
If the breast area is affected by psoriasis, it is recommended that the breast area is not treated
with Curatoderm Ointment or breast-feeding should be stopped. Discuss this with your doctor.
Driving and using machines
Curatoderm Ointment is not expected to have any effect on your ability to drive or use machines.

3. HOW TO USE CURATODERM OINTMENT

3131311

Always use Curatoderm Ointment exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Children: Curatoderm Ointment is not recommended for use in children, as there is limited experience.
Curatoderm Ointment is for use by adults including the elderly.
Curatoderm Ointment can be used on all areas of the body including face, hairline, scalp, armpits, elbows and knees.
Follow your doctor’s instructions for use exactly. The following are general guidelines:
• Apply Curatoderm Ointment once a day, preferably at bedtime.
• Don’t use more than 10 grams of ointment (about the size of a chestnut) each day.
• Spread the ointment thinly over the areas of skin affected by psoriasis.
• If you are using the ointment on your scalp it can be shampooed out the next morning.
• Avoid transfer of the ointment to other areas of your body not affected by psoriasis.
• Wash your hands as soon as you have finished using the ointment.
Duration of treatment
• Your doctor will tell you for how long you need to use the ointment.
If you also use Curatoderm Lotion
• Curatoderm is also available as a lotion. If you are using Curatoderm Lotion, take into the
account that the quantity of applied tacalcitol adds up. You should not use more than
280 micro­grams of tacalcitol per week. That is for example equivalent to 40g Curatoderm
Ointment plus 30ml Curatoderm Lotion per week.
If you use more Curatoderm Ointment than you should
It is important to tell your doctor if you have used too much Curatoderm Ointment, as it may be
necessary to check the amount of calcium in your blood.
If you forget to use Curatoderm Ointment
If you forget to use Curatoderm Ointment at the usual time, use it as soon as you remember, then
carry on as before. Do not apply two doses at the same time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Curatoderm Ointment can cause side effects, although not everybody gets
them.
• Local skin reactions such as itching, burning or redness may be experienced.
• Sometimes the ointment makes your skin redder and more irritated for a short time after you
have applied it.
• On rare occasions, mild contact dermatitis or a worsening of the skin condition may occur.
These are usually mild effects and don’t last very long.
The following side effects have also been reported (frequency not known, cannot be estimated
from the available data)
Elevated calcium levels in the blood (hypercalcaemia)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE CURATODERM OINTMENT

Keep out of the reach and sight of children.
Curatoderm Ointment should be stored below 30°C.
Do not use Curatoderm Ointment after the expiry date which is stated on the label after “EXP:”.
The expiry date refers to the last day of that month.
Do not use for longer than 6 months after first opening the tube.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the environ­
ment.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.